A Bioequivalence Study Comparing Cilnidipine/Valsartan Combination With Coadministration of Cilnidipine and Valsartan

IlDong Pharmaceutical Co Ltd54 enrolled

Overview

A Randomized, Open-label, Single Dosing, Two-way Crossover Clinical Trial to Compare the Safety/Tolerability and Pharmacokinetics of the Combination of Cilnidipine 10mg and Valsartan 160mg in Comparison to Each Component Coadministered in Healthy Male Volunteers

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertension

Interventions

Cilnidipine/ValsartanDRUG

Cilnidipine 10mg/Valsartan 160mg oral on day1 of 14day cycle

Cilnidipine+ValsartanDRUG

Cinidipine 10mg+Valsartan 160mg oral on day1 of 14day cycle

Cilnidipine/ValsartanDRUG

Cilnidipine 10mg/Valsartan 160mg oral on day1 of 14day cycle

Eligibility

Sex: MALEMin age: 19 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age between 20 and 40 * Signed informed consent Exclusion Criteria: * Has a history of hypersensitivity to IP ingredients * Hypertension of hypotension

Outcomes

Primary Outcomes

AUClast

Time frame: 0~24hr

Cmax

Time frame: 0~24hr

Data from ClinicalTrials.gov

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